Description

Lead CMC regulatory affairs activities for biologics products.

This role is remote.

Responsibilities

• Manage CMC regulatory affairs processes for biologics portfolios.
• Oversee technical regulatory documentation and submissions.
• Ensure compliance with global regulatory standards for CMC.
• Direct CMC regulatory strategy and execution.

Required Skills

• 8+ years of experience in Regulatory Affairs.
• Deep expertise in CMC (Chemistry, Manufacturing, and Controls).
• Direct experience managing biologics products.
• Bachelor's degree or equivalent graduate-level education.
• Strong understanding of global regulatory standards.

Key Skills

Education

ANY GRADUATE